Field of the Invention
The present invention generally relates to introducers and introducing assemblies. Specifically, the present invention is directed to a splittable introducer with a notched housing.
Prior Art
Introducer devices provide for access to the venous system and are employed for inserting medical devices such as catheters, guidewires, leads, infusion ports, dialysis ports, dialysis catheters, and others. A typical procedure for gaining access to the central venous system or the arterial system with an introducer is the Seldinger Introduction Method. The Seldinger Method provides for insertion of a needle into the vasculature of a patient. Once the needle is in the vessel, the physician aspirates the needle with a syringe to assure that the needle is in the vessel, and to draw out air present in the bore of the needle. The syringe is removed and discarded. A guide wire is inserted through the needle, and the needle is removed over the guide wire. The introducer, which includes a dilator and a sheath, is placed over the guidewire and inserted into the vessel. With the introducer and wire guide in the vessel, the dilator and wire guide are removed leaving only the sheath in the vessel. The desired medical device is implanted through the passage of the sheath. The sheath is optionally removed from the medical device.
The standard method for accomplishing sheath housing separation is by a mechanical breaking or cracking of the sheath housing in two halves. However, there are problems associated with this method.
First, the force required to initiate sheath housing separation for prior art introducers is relatively high. The application of such a required force may not be possible due to the varying physical strengths of care providers. Furthermore, exerting such an increased amount of force on the introducer device may result in the unintentional movement or dislodgement of the device within the vasculature.
Second, the housing of prior art introducers requires a thin wall thickness. This thin wall thickness is necessitated to promote the initiation and propagation of the crack required to separate the housing. However, the addition of desirable ergonometric and aesthetic features increase the thickness and complexity of the housing, thereby increasing the difficulty and force needed to separate the housing. In addition, such complexities are difficult to manufacture and produce such that the housing consistently splits apart with the application of a repeatable and consistent force.
Therefore, what is desired is an introducer device comprising a housing that separates at a reduced force to initiate subsequent splitting or separation of the sheath. In addition, an introducer housing that repeatably and consistently separates upon the application of a consistent separation force is desired. Furthermore, an introducer assembly that is able to be manufactured more easily and consistently is desired.